FDA 510(k)

Intact® Gen2 System

Номер K: K152596 · 2016-02-15

Дата решения2016-02-15

Код продуктаKNW

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Intact® Gen2 System is the device name listed in this FDA 510(k) record. The listed applicant is Intact Medical Corporation. It received FDA 510(k) clearance on 2016-02-15 under 510(k) number K152596. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Intact® Gen2 System?

Intact® Gen2 System is a medical device that received FDA 510(k) clearance on 2016-02-15. The listed applicant is Intact Medical Corporation. The 510(k) number is K152596.

When did Intact® Gen2 System receive FDA 510(k) clearance?

Intact® Gen2 System received FDA 510(k) clearance on 2016-02-15, under 510(k) number K152596.

Who is the listed applicant for Intact® Gen2 System?

The FDA 510(k) record lists Intact Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intact® Gen2 System?

The FDA product code for Intact® Gen2 System is KNW.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: KNW)

K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLC K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.

Официальный источник

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